Xipamide 20mg tablets

Abstract Triamterene (TRI) and xipamide (XIP) mixture is used as a binary medication of antihypertension which is considered as a major cause of premature death worldwide. The purpose of this research is the quantitative and qualitative analysis of this binary mixture by green univariate and multivariate spectrophotometric methods. Univariate methods were zero order absorption spectra method (D 0 ) and Fourier self-deconvolution (FSD), as TRI was directly determined by D 0 at 367.0 nm in the range (2.00–10.00 µg/mL), where XIP show no interference. While XIP was determined by FSD at 261.0 nm in the range (2.00–8.00 µg/mL), where TRI show zero crossing. Multivariate methods were Partial Least Squares, Principal Component Regression, Artificial Neural Networks, and Multivariate Curve Resolution-Alternating Least Squares. A training set of 25 mixtures with different quantities of the tested components was used to construct and evaluate them, 3 latent variables were displayed using an experimental design. A set of 18 synthetic mixtures with concentrations ranging from (3.00–7.00 µg/mL) for TRI and (2.00–6.00 µg/mL) for XIP, were used to construct the calibration models. A collection of seven synthetic mixtures with various quantities was applied to build the validation models. All the proposed approaches quantitative analyses were evaluated using recoveries as a percentage, root mean square error of prediction, and standard error of prediction. Strong multivariate statistical tools were presented by these models, and they were used to analyze the combined dosage form available on the Egyptian market. The proposed techniques were evaluated in accordance with ICH recommendations, where they are capable of overcoming challenges including spectral overlaps and collinearity. When the suggested approaches and the published one were statistically compared, there was no discernible difference between them. The green analytical method index and eco-scale tools were applied for assessment of the established models greenness. The suggested techniques can be used in product testing laboratories for standard pharmaceutical analysis of the substances being studied.

Abstract licence: CC BY 4.0

The aim – to compare the diuretic effect and tolerability of xipamide and hydrochlorothiazide as second-line diuretics in hospitalized patients with decompensation heart failure (HF), concomitant renal dysfunction and diuretic resistance.Materials and methods. 50 patients with decompensation HF and diuretic resistance were included in the open comparative randomized parallel group study. These patients had refractory to intravenous loop diuretic therapy (LD) (daily diuresis 60 and < 15 ml/min/1.73 m2 were excluded. Results. The study groups were no significant differences in terms of basic demographic, clinical and instrumental parameters and the structure of the treatment; almost half of the patients had generalized edematous syndrome. At the time of randomization, there were no statistically significant differences in daily urine output between patients in both groups, but after randomization, significantly higher values of its output were observed in the xipamide group. This was also consistent with greater weight loss and lower dyspnea severity on the Likert scale on day 5 of treatment in patients receiving xipamide compared with HCT. Compared with xipamide, HCT was associated with increased uric acid levels, worsening of glomerular filtration, and significantly lower plasma K+ levels on the 5th day of treatment. Conclusions. The addition of the non-thiazide sulfonamide diuretic xipamide or HCT to an intravenous loop diuretic in resistance edematous syndrome in patients with decompensation HF and renal dysfunction has unidirectional positive effects in the form of an increase in daily diuresis, a decrease in body weight and a decrease in dyspnea on a Likert scale. Compared with HCT, the use of xipamide is associated with significantly higher values of daily diuresis, greater total weight loss and more significant decrease in dyspnea on a Likert scale. At the same time, unlike xipamide, the use of HCT is associated with an increase in uric acid levels, deterioration of nitrogen-excreting renal function, and a significant decrease in plasma K+ levels. These data provide grounds for preliminary consideration of xipamide as a more effective and potentially safer second-line diuretic in hospitalized patients with HF, concomitant renal dysfunction, and resistance to intravenous LD therapy. 

Abstract licence: CC BY-SA 4.0

A novel, simple and robust high-performance liquid chromatography (HPLC) method was developed and validated for simultaneous determination of xipamide (XIP), triamterene (TRI) and hydrochlorothiazide (HCT) in their bulk powders and dosage forms. Chromatographic separation was carried out in less than two minutes. The separation was performed on a RP C-18 stationary phase with an isocratic elution system consisting of 0.03 mol L(-1) orthophosphoric acid (pH 2.3) and acetonitrile (ACN) as the mobile phase in the ratio of 50:50, at 2.0 mL min(-1) flow rate at room temperature. Detection was performed at 220 nm. Validation was performed concerning system suitability, limits of detection and quantitation, accuracy, precision, linearity and robustness. Calibration curves were rectilinear over the range of 0.195-100 μg mL(-1) for all the drugs studied. Recovery values were 99.9, 99.6 and 99.0 % for XIP, TRI and HCT, respectively. The method was applied to simultaneous determination of the studied analytes in their pharmaceutical dosage forms.

Abstract licence: CC BY-NC-ND 3.0

Abstract In the last few years, the use of surfactants as mobile phase additives in reversed phase liquid chromatography (RPLC) has been steadily developing and improving. Surfactants modify the polarity of the stationary phase which in turn decreases the amount of organic solvent required for elution of the analytes rendering the methodologies linked to them greener and more eco-friendly. Brij-35 is a fatty alcohol ethoxylates non ionic surfactant, which is less widely used as mobile phase additive. Brij-35 can decrease stationary phase polarity while remaining neutral. In this research, Brij-35 was studied in the separation and determination of marketed antihypertensive combination therapy composed of triamterene (TRM) and xipamide (XIP). TRM and XIP are diuretics used for treatment of essential hypertension and associated edema conditions. Chromatographic separation was achieved on RP-C18 column (Kinetix®, 5 µm, 15 cm × 4.6 mm) at flow rate 1 mL min −1 and UV-detection at 254 nm. Isocratic elution was performed using mobile phase composed of 0.1 M Brij-35: methanol (MeOH) (60:40, v/v). The analytes were well separated and quantified within linearity ranges of 5–50 µg mL −1 for both drugs in short retention time (2.6 and 5.3 min. for TRM and XIP, respectively). Since claiming greenness is not enough, Green Analytical Procedure Index (GAPI) was used to demonstrate the superiority of the proposed method over the previously reported methods. GAPI is a new metric for evaluation of the ecological impact of analytical procedures. The proposed method was validated according to ICH guidelines and applied successfully for simultaneous determination of the drugs in their co-formulated tablets.

Abstract licence: CC BY-NC 4.0